Condition category
Musculoskeletal Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alison Carr

ORCID ID

Contact details

Academic Rheumatology
University of Nottingham
Clinical Sciences Building
Nottingham
NG5 1PB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9900285

Study information

Scientific title

Acronym

Study hypothesis

1. Treatment trial: to test the hypothesis that continuous use of simple analgesia in osteoarthritis (OA) knee is more effective in reducing pain in the affected joint than analgesia used on an 'as required' basis.
2. Adherence trial: to test the hypothesis that a simple intervention delivered by practice nurses can increase adherence to continuous analgesia.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis of the knee

Intervention

Treatment trial:
1. Continuous use paracetamol (4 g daily)
2. 'As required' paracetamol (up to 4 g daily as needed)

Adherence trial (all patients in treatment group 1):
1. Individualised educational intervention to promote adherence delivered by practice nurse
2. No intervention

Intervention type

Drug

Phase

Not Specified

Drug names

Paracetamol

Primary outcome measures

Treatment trial: pain in the affected joint measured by 100 mm visual analogue scale
Adherence trial: Proportion of patients who adhere to the regimen for continuous paracetamol

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1999

Overall trial end date

01/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients over 55 years
2. Clinical diagnosis osteoarthritis of the knee
3. Current joint pain score greater than 30 on a 10 mm visual analogue scale

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

244 - Discontinued after March 2002

Participant exclusion criteria

1. Serious concomitant illness
2. Other pain-related conditions
3. Abnormal liver function tests
4. History of analgesic abuse or overdose
5. Severe OA awaiting joint replacement
6. Psychological disorders requiring treatment
7. Patients unable to follow instructions/complete questionnaires.
8. Use of over the counter medication containing paracetamol for duration of the study

Recruitment start date

01/09/1999

Recruitment end date

01/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Rheumatology
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Trial not published due to insufficient number of participants

Publication citations

Additional files

Editorial Notes